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Assist with the remediation process of existing products in efforts to bring the product lines in compliance with the EU MDR regulations for the Product Engineering Surgical franchise
Provide solid technical skill and engineering support for design and development activities for existing products
Participates and/or leads cross-functional teams
Support current products in terms of quality, manufacturing, supply continuity and cost improvement
Participate in executing technical and/or cross-functional project work
Develop and execute test methods which specify measurement equipment, test set-up, measurement systems analysis, and data analysis
Write detailed technical reports based on design verification analysis/testing for design changes and product design activities
Prepares and presents oral and written project updates and technical discussions to relevant stakeholders
Creates, executes and tracks project plans in MS Project to completion while maintaining the overall project budget
Ensure compliance with BD quality policies, procedures and practices as well as with all local, state, federal and BD safety regulations, policies and procedures
Requirements:
BS degree in engineering is required (Mechanical or Biomedical Engineering preferred) with a minimum of 4 years of engineering experience is required, preferably in medical devices or Master’s degree (Mechanical or Biomedical Engineering preferred) with a minimum of three years of engineering experience
Demonstrated ability to utilize MS Project, statistical tools and computer analysis
Design verification/validation protocol and report writing (including statistical data analysis using statistical analysis software)
Develop and coordinate test method and design validation/verification activities